Content about Naltrexone

April 24, 2013
FDA approves drug for opioid-induced constipation

The Food and Drug Administration has approved a new drug for constipation related to use of opioid painkillers made by Sucampo Pharmaceuticals and Takeda Pharmaceuticals, the drug makers said.

BETHESDA, Md. — The Food and Drug Administration has approved a new drug for constipation related to use of opioid painkillers made by Sucampo Pharmaceuticals and Takeda Pharmaceuticals, the drug makers said.

February 25, 2013
FDA approves Amneal opioid-dependence drug

Amneal Pharmaceuticals has received approval from the Food and Drug Administration for a drug to treat opioid dependence.

BRIDGEWATER, N.J. — Amneal Pharmaceuticals has received approval from the Food and Drug Administration for a drug to treat opioid dependence.

Amneal announced Monday the approval of buprenorphine hydrochloride and naloxone hydrochloride sublingual tablets, a generic version of Reckitt Benckiser Healthcare's Suboxone.

Suboxone had sales of $1.5 billion in 2012, according to IMS Health.

 

February 6, 2013
FDA approves Elite Pharmaceuticals' opioid painkiller

The Food and Drug Administration has approved a regulatory approval application from Elite Pharmaceuticals for an opioid painkiller, the drug maker said Wednesday.

NORTHVALE, N.J. — The Food and Drug Administration has approved a regulatory approval application from Elite Pharmaceuticals for an opioid painkiller, the drug maker said Wednesday.

Elite announced the FDA approval of its supplemental application for the manufacture and packaging of naltrexone hydrochloride tablets in the 50-mg strength. The company said the approval would allow it to start manufacturing and packaging the drug for its sales and marketing partner, Mikah Pharma, from which it bought rights to the drug in September 2010.

December 22, 2011
Pfizer announces Embeda post-market trial results

A Pfizer painkiller appears to produce a much less positive experience for recreational drug users when crushed than when administered whole, according to results of a post-marketing clinical study program.

NEW YORK — A Pfizer painkiller appears to produce a much less positive experience for recreational drug users when crushed than when administered whole, according to results of a post-market clinical study program.

October 7, 2011
Watson files for approval of generic painkiller

Watson Pharmaceuticals is looking to become the first to market a generic version of a painkiller made by Pfizer, the drug maker said Friday.

PARSIPPANY, N.J. — Watson Pharmaceuticals is looking to become the first to market a generic version of a painkiller made by Pfizer, the drug maker said Friday.

Watson said it filed a regulatory approval application with the Food and Drug Administration for morphine sulfate and naltrexone hydrochloride extended-release capsules in the 30-mg/1.2-mg, 50-mg/2-mg, 60-mg/2.4-mg, 80-mg/3.2-mg and 100-mg/4-mg strengths. The drug is a generic version of Embeda, made by Pfizer subsidiary King Pharmaceuticals.

September 22, 2011
Orexigen, FDA work out plan for path to approval of obesity drug

Drug maker Orexigen Therapeutics said it had identified a "clear and feasible path" for the approval of its drug for treating obesity by working with the Food and Drug Administration.

SAN DIEGO — Drug maker Orexigen Therapeutics said it had identified a "clear and feasible path" for the approval of its drug for treating obesity by working with the Food and Drug Administration.

August 30, 2011
FDA accepts application for opioid-induced constipation drug

The Food and Drug Administration has accepted a regulatory approval application from Progenics Pharmaceuticals and Salix Pharmaceuticals seeking an additional approval for a pain drug.

TARRYTOWN, N.Y. — The Food and Drug Administration has accepted a regulatory approval application from Progenics Pharmaceuticals and Salix Pharmaceuticals seeking an additional approval for a pain drug.

The two drug makers announced Tuesday that the FDA had accepted their supplemental new drug application for Relistor (methylnaltrexone bromide), an injectable drug for treating opioid-induced constipation.

February 7, 2011
Salix, Progenics ink licensing deal for Relistor

Salix Pharmaceuticals and Progenics Pharmaceuticals have entered a licensing agreement for a drug used to treat side effects of opioid use.

TARRYTOWN, N.Y. — Salix Pharmaceuticals and Progenics Pharmaceuticals have entered a licensing agreement for a drug used to treat side effects of opioid use.

The two companies signed the agreement for Relistor (methylnaltrexone bromide), an injected drug used to treat opioid-induced constipation in patients for whom laxatives haven’t worked.

February 1, 2011
FDA declines to approve Contrave

The Food and Drug Administration has turned down an application for an anti-obesity drug.

SAN DIEGO — The Food and Drug Administration has turned down an application for an anti-obesity drug.

Orexigen Therapeutics and Takeda Pharmaceutical said Tuesday that the FDA had issued a complete response letter for their application for Contrave (naltrexone hydrochloride and bupropion hydrochloride) extended-release tablets.

October 12, 2010
FDA approves Vivitrol

The Food and Drug Administration approved a drug to treat and prevent relapse after patients...

SILVER SPRING, Md. The Food and Drug Administration approved a drug to treat and prevent relapse after patients with opioid dependence have undergone detoxification treatment.

Vivitrol is an extended-release formulation of naltrexone -- which works to block opioid receptors in the brain -- administered by intramuscular injection once a month. It only is administered by a physician.